What are the harms of vaping in young people who have never smoked?

An increase in youth vaping has raised concerns, particularly for young people who have never smoked. However, most vaping by never-smokers is occasional and transient and frequent vaping by never-smokers is rare. Vaping is not risk-free but there is limited evidence of significant harm so far to young people who vape. There is weak evidence that vaping is a gateway to smoking. In fact, the evidence suggests that vaping is diverting young people away from smoking overall and is displacing smoking at a population level. The risk of nicotine dependence is very low in never-smokers who vape. Vaping is likely to be beneficial to young smokers who switch to vaping. Policy measures to reduce vaping are discussed. A tightly regulated, risk-proportionate consumer model is recommended to restrict vaping by young people while allowing easy access for adult smokers, for whom it is an effective and popular quitting aid.

How should nicotine vaping be regulated in Australia?

In Australia, nicotine vaping products are regulated as prescription-only medicines which can only be sold from a pharmacy, with the aim of preventing youth access and allowing use by adult smokers with a doctor's support. The Therapeutic Goods Administration has acknowledged that this policy has not achieved its goals. Instead, a thriving black market has developed which sells unregulated vape products to children and adults. Very few adult vapers use the legal prescription pathway. Regulation should find the optimal balance between facilitating legal access for adult smokers while restricting access by youth. The preferred approach is a tightly regulated consumer model with nicotine vaping products sold by licenced retail outlets with strict age-of-sale verification. Regulations should be proportionate to risk and reflect the lower harms of vaping relative to smoking. A consumer model would bring Australia into line with other Western countries and improve population health.

A critique of the Australian National Health and Medical Research Council CEO statement on electronic cigarettes.

This paper critically analyses a statement by Australia's National Health and Medical Research Council (NHMRC) on e-cigarettes in May 2022 that will be used to guide national policy. We reviewed the evidence and the conclusions drawn in the NHMRC Statement. In our view, the Statement is not a balanced reflection of the benefits and risks of vaping because it exaggerates the risks of vaping and fails to compare them to the far greater risks of smoking; it uncritically accepts evidence of harms from e-cigarettes while adopting a highly sceptical attitude towards evidence of their benefits; it incorrectly claims that the association between adolescent vaping and subsequent smoking is causal; and it understates the evidence of the benefits of e-cigarettes in assisting smokers to quit. The Statement dismisses the evidence that vaping is probably already having a positive net public health effect and misapplies the precautionary principle. Several sources of evidence supporting our assessment were published after the NHMRC Statement's publication and are also referenced. The NHMRC Statement on e-cigarettes does not present a balanced assessment of the available scientific literature and fails to meet the standard expected of a leading national scientific body.

Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial.

BACKGROUND: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation. METHODS: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. DISCUSSION: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au.

An update on vaping and nicotine prescribing.

BACKGROUND: Under 2021 regulations, a prescription is required to import nicotine liquid for vaping or to purchase it from Australian pharmacies. OBJECTIVE: This article outlines 1) the latest evidence on vaping, 2) devices and liquids available, 3) how to counsel smokers about vaping and 4) how to write nicotine prescriptions. DISCUSSION: Vaping is a second-line quitting aid for adult smokers unable to quit with approved treatments and is the most popular quitting method in Australia. It is safer than smoking and more effective than nicotine replacement therapy. It is necessary that general practitioners (GPs) know how vaping works, what products are available, when to consider vaping for smoking patients and how to counsel smokers about it. GPs will be asked to write prescriptions for patients to purchase nicotine liquid from Australian pharmacies under the Authorised Provider Scheme or import it legally. Vaping should cease within 3-6 months if possible; however, long-term vaping is far safer than relapsing to smoking.

Optimal use of smoking cessation pharmacotherapy.

The most effective intervention for stopping smoking is a combination of professional counselling and pharmacotherapy. Medicines are recommended for all smokers who are motivated to quit and are nicotine dependent. Combination nicotine replacement therapy with a patch and an oral product is more effective than the patch alone. An adequate dose of nicotine must be used for an adequate duration. Varenicline is the most effective oral drug. It is safe in people with stable mental illness. Vaping nicotine is a second-line treatment which can be considered for smokers who are unable to quit with other methods.

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.